MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-17-S

Device Problems Crack (1135); Material Discolored (1170); Inadequate Storage (1600)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2013

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Udi #: (b)(4).Contact office and manufacturing site should reflect: (b)(4).Manufacturer's ref.No: (b)(4).Event description continuation: the bwi failure analysis lab received the catheter on june 12, 2015.The catheter was returned unopened with blue material loose in the pouch and the catheter shaft material had cracks and shaved areas next to shaft protector.The mounting card has black marks on it and also the pouch plastic covering on the inside.Even though the investigation related to (b)(4) confirmed that the condition reported by the physician was related to exposure to ultraviolet light from the sun, this event is being reported because the bwi failure analysis lab received the device for evaluation and found blue material loose in the pouch and the catheter shaft material had cracks and shaved areas next to shaft protector.Also the mounting card has black marks on it and also the pouch plastic covering on the inside.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The awareness date reflecting the catheter integrity issue is june 12, 2015.

Event Description

It was reported that this unopened navistar thermocool catheter was stored in the same area as the catheter alleged under 9673241-2013-00346 (manufacturers reference no: (b)(4)) where it was described that the blue shaft coating of the catheter, all the way to the base, started fraying off when they touched it.The account believed that the storage site was the root cause of the issue.Multiple attempts had been made to obtain the product for this complaint.However, the product had not been returned for investigation.Since there was no evidence that this catheter had any issue, this complaint was assessed as not reportable.However, since this catheter was from the same hospital and stored in the same storage area as 9673241-2013-00346 (manufacturers reference no: (b)(4)).The investigation related to (b)(4) confirmed that the condition reported by the physician was related to exposure to ultraviolet light from the sun.It was confirmed that the devices were stored outside of their boxes facing the sunlight.The hospital was notified about the improper storage of the devices.The ifu states to store the catheters in a cool, dry place.Storage temperature should be between 5 and 25c (41 and 77 f).An ultraviolet conditioning testing was performed to try to reproduce the reported condition over some good catheter samples.The results demonstrated that the samples were discolored and the shafts were found cracked, exhibiting the same condition as the reported device.Therefore, the reported customer complaint has been verified.However, the evidence and the investigation showed that the catheter was manufactured accordingly and that external factors contributed to the shaft degradation.

Manufacturer Narrative

(b)(4).It was reported that this unopened navistar thermocool catheter was stored in the same area as the catheter alleged under 9673241-2013-00346 (manufacturers reference no: (b)(4)).The account believed that the storage site was the root cause of the issue.The catheters were stored close to a window outside their boxes exposing the devices to the sunlight.Fifteen pieces were received with the pouch and plastic film sealed from the aria hospital.All devices presented, yellowing packaging, shaft peels and the lots were expired.Samples were sent to material evaluation.Results show that the yellowing condition is consistent with uv exposition.It was confirmed that the catheters show an evident degradation of the material which may be expected based on the storage condition reported above.The instructions for use (ifu) for storage showed that the catheter should be stored in a cool, dry, dark place.Storage temperature should be between 5 and 25ºc (41 and 77ºf).The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.However the root cause is related to the storage conditions at the hospital.

• Brand Name: NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4904534
• MDR Text Key: 22389911
• Report Number: 9673241-2015-00437
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 15853126M
• Other Device ID Number: (01)10846835000566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1